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NDC 50804-0876-43 Rubbing 70 mL/100mL Details

Rubbing 70 mL/100mL

Rubbing is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Perrigo Direct, Inc.. The primary component is ALCOHOL.

Product Information

NDC	50804-0876
Product ID	50804-876_1cbcd45b-3afb-4ebf-87bf-ecf7c3c79559
Associated GPIs	96201020202070
GCN Sequence Number	045156
GCN Sequence Number Description	ethyl alcohol SOLUTION 70 % TOPICAL
HIC3	Q5B
HIC3 Description	TOPICAL PREPARATIONS,ANTIBACTERIALS
GCN	12232
HICL Sequence Number	001681
HICL Sequence Number Description	ETHYL ALCOHOL
Brand/Generic	Generic
Proprietary Name	Rubbing
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Perrigo Direct, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50804-0876-43 (50804087643)

Pricing Information	N/A
NDC Package Code	50804-876-43
Billing NDC	50804087643
Package	473 mL in 1 BOTTLE, PLASTIC (50804-876-43)
Marketing Start Date	2009-05-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ba2266d7-da25-495a-b035-97e149551c30 Details

Active Ingredient

Ethyl alcohol 70%

Purpose

First aid antiseptic

Use

first aid to help prevent the risk of infection in:

minor cuts
scrapes
burns

Warnings

For external use only

Flammable. Keep away from fire or flame, heat, spark, electrical.

Ask a doctor before use

for deep or puncture wounds, animal bites or serious burns

When using this product

do not get into eyes
do not inhale
do not apply over large areas of the body
do not use longer than 1 week

Stop use and ask a doctor if

condition persists or gets worse

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Caution

Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

Directions

clean the affected area
apply a small amount of this product on the affected area 1 to 3 times daily
may be covered with a sterile bandage
if bandage, let dry first

other information

will produce serious gastric disturbances if taken internally

Inactive ingredient

acetone, denatonium benzoate, methyl isobutyl ketone, water

SPL UNCLASSIFIED SECTION

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

principal display panel

NDC 50804-876-43

Good Sense

Ethyl

Rubbing

Alcohol

70% by volume

First Aid Antiseptic
For Rubbing and Massaging

WARNING FLAMMABLE Keep awa from heat, spark, electrical, fire or flame

Use only in a well ventilated area:

fumes can be harmful

CAUTION: Do not point at self or

others; product will squirt when squeezed.

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

RUBBING

ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-876
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ACETONE (UNII: 1364PS73AF)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
METHYL ISOBUTYL KETONE (UNII: U5T7B88CNP)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-876-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/18/2009

Labeler - Perrigo Direct, Inc. (076059836)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(50804-876)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(50804-876)

Revised: 10/2022

Document Id: 1cbcd45b-3afb-4ebf-87bf-ecf7c3c79559

Set id: ba2266d7-da25-495a-b035-97e149551c30

Version: 15

Effective Time: 20221027